# K033793: Cleaner II Rotational Thrombectomy System

- Pathway: 510(k) (Traditional)
- Applicant: Rex Medical
- Decided: Dec 16, 2003 after 11 days
- Product code: MCW (Catheter, Peripheral, Atherectomy)
- Device class: 2
- Regulation: 21 CFR 870.4875
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K954234 (1995). 13 ancestors in all.
12 later devices descend from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031610: Rex Medical Cleaner Rotational Thrombectomy System, Rex Medical (2003) Summary page 1.
- K902327: Embolectomy Catheter, Clincal Instruments Corp. (1991) Summary page 1.
- K032393: Induction and Sampling Manifold (or Stopcock), Elcam Medical Acal (2003) Summary page 1.
- K022170: Inner-Lock Locking Introducer Sheaths, Rex Medical (2003) Summary page 1.
- K032569: Short Introducer Sheath, Rex Medical (2003) Summary page 1.

## Most influential descendants
- K040252: Cleaner Rotational Thrombectomy System Kit (2004), 11 descendants of its own
- K060904: Cleaner Rotational Thrombectomy System (2006), 10 descendants of its own
- K091029: Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X 120 CM) (2010), 9 descendants of its own
- K120346: Cleaner Rotational Thrombectomy System (2012), 8 descendants of its own
- K141617: Cleaner Rotational Thrombectomy System (2014), 7 descendants of its own

## Indications for use
The Rex Medical Cleaner II Rotational Thrombectomy System permits mechanical declotting and removal of thrombi and emboli in synthetic grafts. The Embolectomy balloon component, located on the Cleaner II Device, may be used for subsequent Embolectomy procedures to remove emboli and thrombi in the arterial system communicating with the synthetic dialysis graft

Source page: https://510kreport.com/device/K033793
Methodology: https://510kreport.com/methodology